MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LAMP, SURGICAL

Model Number	ARDLCA219001A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 28th of april, 2022 getinge became aware of an issue with lucea 100 - surgical light.As it was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Additional Manufacturer Narrative
According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer reference number: (b)(4).
Event or Problem Description
On 28th of april, 2022 getinge became aware of an issue with lucea 100 - surgical light.It was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.After sme investigation it was clarified the maquet¿s surgical lights cannot catch fire, because the cables are ul certified.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no possibility of a fire, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 28th of april, 2022 getinge became aware of an issue with lucea 100 - surgical light.As it was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.Corrected b5 describe event and problem: on 28th of april, 2022 getinge became aware of an issue with lucea 100 - surgical light.It was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.After sme investigation it was clarified the maquet¿s surgical lights cannot catch fire, because the cables are ul certified.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no possibility of a fire, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
Getinge became aware of an issue with lucea 100 - surgical light.It was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.After investigation performed by subject matter expert at manufacturing site it was clarified the maquet¿s surgical lights cannot catch fire, because the cables are ul certified.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no possibility of a fire, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.The event which is investigated herein is not safety related, since the cables are ul certified and under metallic enclosures, and therefore the device could not have contributed to the hazardous event in that way.However, the device did fail to meet its specification due to bad electrical contact.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing customer product complaints for this type of issues we were able to establish that the incidents regarding bad electrical contact are occurring at a low ratio on powerled and hled surgical lights.A root cause evaluation for performed by subject matter expert at manufacturing site for the problem regarding the connector between the spring arm and the cupola fork which had been found melted and the cupola would not be able to operate correctly.As stated by the sme, such an issue is due to a bad electrical contact which generate the heat and melt the plastic connector.This bad electrical contact is probably due to a bad holding of the pin inside the connector.The pins are plugged/inserted by the product line operator at the factory.Therefore, issue is probably related to the production factory product line operator.Given the circumstances, getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with lucea 100 - surgical light.It was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.After sme investigation it was clarified the maquet¿s surgical lights cannot catch fire, because the cables are ul certified.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no possibility of a fire, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Corrected b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with lucea 100 - surgical light.It was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.After investigation performed by subject matter expert at manufacturing site it was clarified the maquet¿s surgical lights cannot catch fire, because the cables are ul certified.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no possibility of a fire, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
Event or Problem Description
On (b)(6) 2022 getinge became aware of an issue with lucea 100 - surgical light.It was stated, connection between spring arm and fork has overheated.There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.After investigation performed by subject matter expert at manufacturing site it was clarified the maquet¿s surgical lights cannot catch fire, because the cables are ul certified.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no possibility of a fire, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: LUCEA 100
• Common Device Name: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14315221
• Report Number: 9710055-2022-00146
• Device Sequence Number: 17393547
• Product Code: FTD
• UDI-Device Identifier: 03700712400651
• UDI-Public: 3700712400651
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA219001A
• Device Catalogue Number: ARDLCA219001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 08/04/2022; 10/26/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/14/2022; 08/29/2022; 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown